CAZ · Class II · 21 CFR 868.5140

FDA Product Code CAZ: Anesthesia Conduction Kit

This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.

Leading manufacturers include Arrow Intl., Inc., Kendall Healthcare Products Co. Div.Of Tyco Health and PAJUNK GmbH Medizintechnologie.

156
Total
156
Cleared
129d
Avg days
1976
Since
156 devices
25–48 of 156
Cleared Oct 27, 2008
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K082164
PAJUNK GmbH Medizintechnologie
Anesthesiology · 88d
Cleared Jul 09, 2008
BUSSE PLASTIC LOR SYRINGE
K080804
Busse Hosipital Disposables
Anesthesiology · 110d
Cleared Apr 22, 2008
PERIPHERAL NERVE BLOCK SUPPORT TRAY
K073187
Life-Tech, Inc.
Anesthesiology · 161d
Cleared Jun 20, 2007
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282
B.Braun Medical, Inc.
Anesthesiology · 232d
Cleared Jun 07, 2007
PAJUNKS EPILONG SET PEDIATRIC
K062902
PAJUNK GmbH Medizintechnologie
Anesthesiology · 253d
Cleared Jan 22, 2007
GLASS LOSS OF RESISTANCE SYRINGE
K063018
Busse Hospital Disposables, Inc.
Anesthesiology · 112d
Cleared Jan 12, 2007
PAJUNKS STIMULONG TSUI-METHOD SET
K062900
PAJUNK GmbH Medizintechnologie
Anesthesiology · 107d
Cleared Dec 18, 2006
LOSS OF RESISTANCE SYRINGE
K061737
Robert Busse & Co., Inc.
Anesthesiology · 181d
Cleared Jul 18, 2006
POLYPLEX STIMULATING CATHETER SYSTEM
K060186
Te ME NA Sas
Anesthesiology · 175d
Cleared Jun 13, 2006
EPILONG KIT FOR ANESTHESIOLOGY
K060311
PAJUNK GmbH Medizintechnologie
Anesthesiology · 125d
Cleared Jun 02, 2006
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K060563
Pajunk GmbH
Anesthesiology · 114d
Cleared Feb 15, 2006
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
K052954
Life-Tech, Inc.
Anesthesiology · 118d
Cleared Jan 12, 2006
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K053283
Pajunk GmbH
Anesthesiology · 48d
Cleared Dec 08, 2005
MPS ACACIA NERVE BLOCK NEEDLE
K052946
Mps Acacia
Anesthesiology · 49d
Cleared Aug 26, 2005
STINGRAY EPIDURAL CATHETER CONNECTOR
K051171
Epimed International, Inc.
Anesthesiology · 112d
Cleared Dec 21, 2004
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K043130
Pajunk GmbH
Anesthesiology · 39d
Cleared Jun 16, 2004
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
K041158
Atrion Medical Products, Inc.
Anesthesiology · 44d
Cleared May 05, 2004
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K033018
Pajunk GmbH
Anesthesiology · 222d
Cleared Mar 10, 2004
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033080
Portex, Inc.
Anesthesiology · 163d
Cleared Feb 04, 2004
PERIFIX CATHETER CONNECTOR
K033952
B.Braun Medical, Inc.
Anesthesiology · 44d
Cleared Jan 15, 2004
B-SMART, MODEL B-01
K031128
Macosta Medical USA, LLC
Anesthesiology · 281d
Cleared Oct 01, 2003
PERIFIX CATHETER CONNECTOR
K032144
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Sep 09, 2003
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
K022752
Hdc Corp.
Anesthesiology · 386d
Cleared Apr 23, 2003
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
K030937
Arrow International, Inc.
Anesthesiology · 29d